Z-0290-2022Class II

Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE

Name: Z-0290-2022 Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
Creator: Medtronic Vascular, Inc.
Published: 2021-10-15
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2021-10-15 / Open, Classified

FDA source

Medtronic Vascular, Inc. began a recall of Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE on 2021-10-15. FDA classified it as Class II and gives the reason as "During stent graft deployment, the spindle may detach from the distal end of the spindle hypotube". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0290-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-10-15
Posted: 2021-11-24
Recalling firm: Medtronic, Inc.
Product: Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
Product code: MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Reason for recall: During stent graft deployment, the spindle may detach from the distal end of the spindle hypotube
FDA root cause: Under Investigation by firm
Action: On or about 10/15/2021, the firm initiated a global verbal notification to customers informing them that is the potential for a specific subset of 18Fr Stent Graft Systems to have the potential for the spindle to detach from the spindle hypotube during deployment. On 10/18/2021, the firm sent an "URGENT MEDICAL DEVICE RECALL" Notification Letter via UPS 2-day delivery. Customers are instructed to take the following actions: 1) Return all unused affected devices to the Recalling Firm via their sales representative or calling customer service at 1-888-283-7868 or email [email protected]. 2) Complete the enclosed Customer Confirmation Form and email to [email protected]. 3) Forward this Recall notice to all those who need to be aware within their organization to include physician implanters (US only). Additionally, if any affected devices have been distributed to other organizations, forward this notice to those entities. For questions or assistance - contact their Field Representative or Customer Service at 888-283-7868 or email [email protected].
Quantity in commerce: 2 devices
Distribution: Worldwide distribution - U.S. Nationwide distribution in the states of CA, FL, GA, MN, MO, NC, NJ, NM, NV, NY, PA, SC, TN, TX, VA, and WV. The countries of Austria, Belgium, Bulgaria, China, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Japan, Jordan, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Qatar, South Africa, Spain, Sweden, Switzerland, and United Kingdom.
Product codes and lots: Model Number/Product Descripton: ENTF2525C70EE/STENT GRAFT ENTF2525C70EE ENDURANT TUBE GTIN Code: 00763000006129 Serial Numbers: V30624638 V30624639

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0290-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0290-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-12-01	2021-11-24
Z-0291-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-12-01	2021-11-24
Z-0292-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-12-01	2021-11-24

Product code MIH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)